Filed pursuant to Rule 424(b)(3)
Registration No. 333 - 38901
PROSPECTUS
ICN PHARMACEUTICALS, INC.
630,113 SHARES OF COMMON STOCK
This Prospectus relates to up to 46,818 shares of Common Stock,
par value $0.01 per share (the "Common Stock"), of ICN
Pharmaceuticals, Inc., a Delaware corporation ("ICN" or the
"Company"), issuable by the Company upon the exercise of its
outstanding five-year representatives warrants (the "Warrants") issued
to H.J. Meyers & Co., Inc. ("Meyers") or its designees (the "Warrant
holders"). The Warrants are exercisable until January 27, 1998, at an
exercise price of $18.7151. This Prospectus also relates to an
offering of up to 551,595 shares of Common Stock that may be issued
upon the exchange of the new and old Bio Capital Holding Swiss Franc
Exchangeable Certificates due February 17, 2002, in the aggregate
principal amounts of Swiss Francs 37,870,000 and 1,745,000,
respectively (collectively, the "Certificates"), of Bio Capital
Holding, a Guernsey, Channel Islands trust. Cash will be paid in lieu
of fractional shares upon the exchange of the Warrants or the
Certificates.
In addition, this Prospectus relates to the resale of up to
31,700 shares (the "Rzeszow Shares") of Common Stock that may from
time to time be offered or sold by certain employees (the "Rzeszow
Employees") of Polfa Rzeszow S.A. ("Rzeszow"), a Polish pharmaceutical
company.
The Warrants were issued originally by Viratek, Inc. ("Viratek")
in connection with an offering by Viratek of units. From and after the
combination on November 10, 1994 (the "Merger") of ICN
Pharmaceuticals, Inc. ("Old ICN"), SPI Pharmaceuticals ("SPI"),
Viratek, and ICN Biomedicals, Inc. ("Biomedicals") (collectively, the
"Predecessor Companies"), the Warrants and Certificates have been
exchangeable into shares of Common Stock. In conjunction with the
Merger, SPI, Old ICN and Viratek merged into ICN Merger Corp., and
Biomedicals merged into ICN Subsidiary Corp., a wholly owned
subsidiary of ICN Merger Corp., and ICN Merger Corp. was renamed ICN
Pharmaceuticals, Inc.
As of December 16, 1997, the new and old Certificates were
exchangeable into Common Stock at prices of $47.146 and $81.259,
respectively, per share, subject to adjustment for dilutive issues.
Accordingly, each new and old Certificate representing 5000 Swiss
Francs principal amount is exercisable into 70.99 and 39.96 shares of
Common Stock, respectively. For the purposes of calculating the number
of shares issued on exchange of the Certificates, the exchange rates
of 1.494 and 1.59 Swiss Francs per U.S. Dollar are used throughout the
life of the new and old Certificates, respectively.
In connection with ICN's acquisition of an 80% interest in
Rzeszow, ICN agreed to issue the Rzeszow Shares covered by this
Prospectus to the Rzeszow Employees. The offer and sale of the Rzeszow
Shares to the Rzeszow Employees will be made outside the United States
in compliance with Regulation S of the Securities Act of 1933, as
amended (the "Securities Act").
The Company has agreed to bear all expenses in connection with
the registration of the Common Stock on behalf of the Warrant holders,
the Certificate holders, and the Rzeszow Employees.
The Rzeszow Employees and any broker-dealers, agents or
underwriters that participate with the Rzeszow Employees in the
distribution of the Rzeszow Shares may be deemed to be "underwriters"
within the meaning of the Securities Act and any commissions received
by such broker-dealers, agents or underwriters and any profit on the
resale of the Rzeszow Shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
The Common Stock is traded on the New York Stock Exchange
("NYSE") under the symbol "ICN." On December 16, 1997, the closing
sale price per share, as reported by the NYSE, was $49.9375.
The Rzeszow Shares may be sold from time to time by the Rzeszow
Employees, or, in certain cases, by their transferees or assignees.
Such sales may be made in the over-the-counter market, on the NYSE or
other exchanges (if the Common Stock is listed for trading thereon),
or otherwise at prices and at terms then prevailing, at prices related
to the then current market price or at negotiated prices. The Rzeszow
Shares may be sold by any one or more of the following methods: (a) a
block trade in which the broker or dealer so engaged will attempt to
sell the securities as agent but may position and resell a portion of
the block as principal to facilitate the transaction; (b) purchases by
a broker or dealer as principal and resale by such broker or dealer
for its account; (c) ordinary brokerage transactions and transactions
in which the broker solicits purchasers; and (d) privately negotiated
transactions. In addition, any Rzeszow Shares that qualify for sale
pursuant to Rule 144 may be sold under Rule 144 rather than pursuant
to this Prospectus.
AN INVESTMENT IN THE COMMON STOCK OFFERED HEREBY INVOLVES A HIGH
DEGREE OF RISK. SEE "RISK FACTORS."
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION
NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS.
ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The Date of this Prospectus is December 19, 1997.
Information contained herein is subject to completion or amendment. A
Registration Statement relating to these securities has been filed
with the Securities and Exchange Commission. These Securities may not
be sold nor may offers to buy be accepted prior to the time the
Registration Statement becomes effective. This Prospectus shall not
constitute an offer to sell or the solicitation of an offer to buy nor
shall there be any sale of these securities in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction.
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the
Securities Exchange Act of 1934, as amended (the "Exchange Act"), and
in accordance therewith files reports, proxy statements and other
information with the Securities and Exchange Commission (the
"Commission" or "SEC"). Such reports, proxy statements and other
information filed by the Company may be inspected and copies obtained
(at prescribed rates) at the public reference facilities maintained by
the Commission in Washington, D.C. at 450 Fifth Street, N.W.,
Judiciary Plaza, Washington, D.C. 20549, and at the Commission's
Regional Offices in New York, at 7 World Trade Center, 13th Floor, New
York, New York 10048, and in Chicago, at Citicorp Center, 500 West
Madison Street, Suite 1400, Chicago, Illinois 60661. Copies of such
material can be obtained (at prescribed rates), by writing to the
Public Reference Section of the Commission, 450 Fifth Street, N.W.,
Washington, D.C. 20549. Such material also is available through the
Commission's Website (http://www.sec.gov). Such material also can be
inspected at the NYSE, 20 Broad Street, New York, New York 10005, on
which the Common Stock is listed.
This Prospectus is part of a Registration Statement on Form S-3
(together with all amendments and exhibits thereto, the "Registration
Statement") filed by the Company with the Commission under the
Securities Act with respect to the Common Stock. This Prospectus does
not contain all the information set forth or incorporated by reference
in the Registration Statement and the exhibits and schedules relating
thereto, certain portions of which have been omitted as permitted by
the Commission's rules and regulations. For further information with
respect to the Company and the Common Stock offered hereby, reference
is made to the Registration Statement and the exhibits thereto which
are on file at the offices of the Commission and may be obtained upon
payment of the fee prescribed by the Commission as described above.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following reports and documents filed by the Company with the
Commission pursuant to the Exchange Act are incorporated into this
Prospectus by reference as of their respective dates:
1. Annual Report on Form 10-K for the fiscal year ended
December 31, 1996, dated March 31, 1997, as amended by Form
10-K/A, dated July 24, 1997.
2. Quarterly Report on Form 10-Q for the three months ended
March 31, 1997, dated May 15, 1997.
3. Quarterly Report on Form 10-Q for the three months ended
June 30, 1997, dated August 14, 1997.
4. Quarterly Report on Form 10-Q for the three months ended
September 30, 1997, dated November 14, 1997.
5. Current Report on Form 8-K, dated December 18, 1997.
6. The description of the Common Stock and associated Preferred
Stock Purchase Rights contained in the Registration
Statement on Form 8-A, dated November 10 ,1994.
All reports and other documents filed by the Company pursuant to
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent to
the date of this Prospectus and prior to the termination of the
offering of the Common Stock pursuant to this Prospectus (this
"Offering") shall be deemed to be incorporated by reference in this
Prospectus and to be a part hereof from the date of filing of such
reports and documents. Any statement contained herein or in a report
or document incorporated or deemed to be incorporated herein by
reference shall be deemed to be modified or superseded for purposes of
this Prospectus to the extent that a statement contained herein or in
any subsequently filed report or document that is or is deemed to be
incorporated by reference herein modifies or supersedes such
statement. Any statement so modified or superseded shall not be
deemed, except as so modified or superseded, to constitute a part of
this Prospectus.
The making of a modifying or superseding statement shall not be
deemed an admission for any purpose that the modified or superseded
statement, when made, constituted a misrepresentation, an untrue
statement of a material fact or an omission to state a material fact
that is required to be stated or that is necessary to make a statement
not misleading in light of the circumstances in which it was made.
THE COMPANY WILL PROVIDE, WITHOUT CHARGE, TO EACH PERSON TO WHOM
A COPY OF THIS PROSPECTUS IS DELIVERED, ON THE REQUEST OF SUCH PERSON,
A COPY OF ANY OR ALL OF THE REPORTS AND DOCUMENTS INCORPORATED HEREIN
BY REFERENCE (OTHER THAN EXHIBITS THERETO, UNLESS SUCH EXHIBITS ARE
SPECIFICALLY INCORPORATED BY REFERENCE INTO SUCH REPORTS OR
DOCUMENTS). WRITTEN REQUESTS FOR SUCH COPIES SHOULD BE DIRECTED TO
DAVID C. WATT, EXECUTIVE VICE PRESIDENT, GENERAL COUNSEL AND CORPORATE
SECRETARY, ICN PHARMACEUTICALS, INC., 3300 HYLAND AVENUE, COSTA MESA,
CALIFORNIA 92626. TELEPHONE INQUIRIES MAY BE DIRECTED TO DAVID C. WATT
AT (714) 545-0100.
THE COMPANY
ICN is a multinational pharmaceutical company that develops,
manufactures, distributes and sells pharmaceutical, research and
diagnostic products and provides radiation monitoring services. The
Company pursues a strategy of international expansion which includes
(i) the consolidation of the Company's leadership position in Eastern
Europe and Russia; (ii) the acquisition of high margin products that
complement existing product lines and can be registered and introduced
into additional markets to meet the specific needs of those markets;
and (iii) the creation of a pipeline of new products through internal
research and development, as well as strategic partnerships and
licensing arrangements. References to ICN or the Company include the
subsidiaries of ICN, unless the context requires otherwise.
The Company distributes and sells a broad range of prescription
and over-the-counter pharmaceutical and nutritional products in over
60 countries worldwide, primarily in North America, Latin America,
Western Europe and Eastern Europe. These pharmaceutical products treat
viral and bacterial infections, diseases of the skin, myasthenia
gravis, cancer, cardiovascular disease, diabetes and psychiatric
disorders. Among the Company's products is the broad spectrum
antiviral agent ribavirin, which is marketed in the United States,
Canada and most of Europe under the trade name Virazole(R).
Virazole(R) is currently approved for commercial sale in over 40
countries for one or more of a variety of viral infections, including
respiratory syncytial virus ("RSV"), herpes simplex, influenza,
chicken pox, hepatitis and human immunodeficiency virus (HIV). In the
United States, Virazole(R) is approved only for use in hospitalized
infants and young children with severe lower respiratory infections
due to RSV.
The Company believes it has substantial opportunities to realize
growth from its internally developed compounds. These compounds are
the result of significant investments in its research and development
activities related to nucleic acids conducted over three decades. On
July 28, 1995, the Company entered into an Exchange License and Supply
Agreement (the "Agreement") and a Stock Purchase Agreement with a
subsidiary of Schering-Plough Corporation ("Schering") to license the
Company's proprietary drug ribavirin as a treatment for chronic
hepatitis C in combination with Schering's alpha interferon (the
"Combination Therapy"). The Agreement provided the Company an initial
non-refundable payment by Schering of $23,000,000, and future royalty
payments to the Company for marketing of the drug, including certain
minimum royalty rates. Schering will have exclusive marketing rights
for ribavirin for hepatitis C worldwide, except that the Company will
retain the right to co-market in the countries of the European
Economic Community. In addition, Schering will purchase up to
$42,000,000 in Common Stock upon the achievement of certain regulatory
milestones. Under the Agreement, Schering is responsible for all
clinical developments and regulatory activities worldwide. During
1996, clinical trials commenced with the enrollment of more than 2000
patients. In December 1997, the Company was informed by Schering that
Schering had filed a New Drug Application for the Combination Therapy
with the U.S. Food and Drug Administration (the "FDA"). See "Risk
Factors -- No Assurance of Successful Development and
Commercialization of Future Products."
The Company believes it is positioned to expand its presence in
the pharmaceutical markets in Eastern and Central Europe. In 1991, a
75% interest was acquired in Galenika Pharmaceuticals ("Galenika"), a
large drug manufacturer and distributor in Yugoslavia. Galenika was
subsequently renamed ICN Yugoslavia. This acquisition added new
products and significantly expanded the sales volume of the Company.
With the investment in ICN Yugoslavia, the Company became one of the
first Western pharmaceutical companies to establish a direct
investment in Eastern Europe. ICN Yugoslavia continues to be a
significant part of the Company's operations although its sales and
profitability have, at times, been substantially diminished owing
principally to the imposition of sanctions on Yugoslavia by the United
Nations. However, the United Nations Security Council adopted
resolutions, that in December 1995, suspended and, in October 1996,
lifted economic sanctions imposed on the Federal Republic of
Yugoslavia since May of 1992. The suspension and lifting of economic
sanctions enabled ICN Yugoslavia to resume exporting certain of its
product lines to Russia, other Eastern European Markets, Africa, the
Middle East and the Far East. See "Risk Factors -- Risk of Operation
in Yugoslavia."
In 1995, the Company acquired a 75% interest in Oktyabr, one of
the largest pharmaceutical companies in the Russian Federation. In
1996, the Company purchased an additional 15% interest in Oktyabr,
raising its ownership to 90%. Additionally, in 1996 and 1997 the
Company greatly expanded its Russian presence through the acquisition
of four additional pharmaceutical companies: Leksredstva, located in
Kursk; Polypharm, located in Chelyabinsk; Marbiopharm, located in
Yoshkar-Ola; and AO Tomsky Chemical and Pharmaceutical Plant ("Tomsk")
located in Tomsk. The combined sales of these five companies establish
the Company among the largest pharmaceutical companies in Russia today
and a pioneer and leader in the privatization movement. In 1996, the
Company acquired a 60% interest in Alkaloida Chemical Co.
("Alkaloida"), one of the largest pharmaceutical companies in terms of
sales in Hungary and a major world producer of morphine and related
compounds. In October 1997, the Company acquired an 80% interest in
Rzeszow, a pharmaceutical company located in Poland. The Company is
currently exploring acquisition opportunities in Russia and the Czech
Republic. See "Risk Factors -- Risk of Operations in Eastern Europe,
Russia and China."
In August 1997, ICN Puerto Rico, Inc. (the "Subsidiary") acquired
the worldwide rights (except India) to seven products: Alloferin,
Ancotil, Glutril, Limbitrol, Mestinon, Prostigmin and Protamin from F.
Hoffmann-La Roche Ltd. ("Roche"). The Subsidiary also obtained
worldwide rights outside of the United States and India to Efudix and
Librium. The Company received the product rights in exchange for
$90,000,000 payable in a combination of 1,600,000 shares of the
Company's Common Stock valued at $40,000,000 and 2,000 shares of a new
issue of the Company's convertible preferred stock valued at
$50,000,000. Each share of the Company's convertible preferred stock
is convertible into 1,000 shares of Common Stock at a conversion price
equivalent to $25 per share. The Company guaranteed Roche a price
initially at $25.75 per share of Common Stock, increasing at a rate of
6% per annum for three years, with the Company being entitled to any
proceeds realized by Roche from the sale of these shares during the
guarantee period in excess of the guaranteed price. Also in August
1997, the Subsidiary purchased Roche's Humacao, Puerto Rico
manufacturing plant (the "Humacao, Puerto Rico Plant"), which meets
current U.S. Food and Drug Administration Good Manufacturing Practices
for various products, including: Aleve, Naprosyn, EC Naprosyn, Anaprox
and Cytovene, for $55,000,000 in cash and the assumption of certain
debt. Simultaneously, Roche leased the Humacao, Puerto Rico Plant from
the Company for two years at $8,000,000 per annum. On December 5,
1997, the Company acquired the worldwide rights to Levo-Dromoran and
Tensilon from subsidiaries of Roche, and pursuant to an option granted
by Roche to the Company in connection with the August 1997
transaction, the Company obtained the U.S. rights to Efudix and
Librium for a total aggregate purchase price of approximately
$89,000,000 (the purchase price for which was paid utilizing the price
appreciation in the Common Stock issued to Roche in August 1997).
In addition to its pharmaceutical operations, the Company also
develops, manufacturers and sells, through its wholly owned
subsidiary, ICN Biomedicals, Inc., a broad range of research and
diagnostic products and radiation monitoring services. The Company
markets these products internationally to major scientific, academic,
health care and governmental institutions through catalog and direct
mail marketing programs.
The principal executive offices of the Company are located at
3300 Hyland Avenue, Costa Mesa, California 92626. The telephone number
at such address is (714) 545-0100.
RISK FACTORS
An investment in the Common Stock involves a high degree of risk
and may not be appropriate for investors who cannot afford to lose
their entire investment. A holder of the Certificates should be fully
aware of the risk factors set forth herein, when evaluating whether to
convert their Certificates into Common Stock. This Prospectus contains
or incorporates statements that constitute forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of
1995. Those statements appear in a number of places in this Prospectus
and in the documents incorporated by reference and may include
statements regarding, among other matters, the Company's growth
opportunities, the Company's acquisition strategy, regulatory matters
pertaining to governmental approval of the marketing or manufacturing
of certain of the Company's products and other factors affecting the
Company's financial condition or results of operations. Prospective
investors are cautioned that any such forward-looking statements are
not guarantees of future performance and involve risks, uncertainties
and other factors which may cause actual results, performance or
achievements to differ materially from the future results, performance
or achievements expressed or implied in such forward-looking known and
unknown statements. Such factors include the various risk factors
described below.
DEPENDENCE ON FOREIGN OPERATIONS
Approximately 75% and 80% of the Company's net sales for 1995 and
1996, respectively, and approximately 78% and 80% of the Company's net
sales for the nine months ended September 30, 1996 and 1997,
respectively, were generated from operations outside the United
States. The Company operates directly and through distributors in
North America, Latin America (principally Mexico), Western Europe and
Eastern Europe and through distributors elsewhere in the world.
Foreign operations are subject to certain risks inherent in conducting
business abroad, including possible nationalization or expropriation,
price and exchange controls, limitations on foreign participation in
local enterprises, health-care regulation and other restrictive
governmental actions. Changes in the relative values of currencies
take place from time to time and may materially affect the Company's
results of operations. Their effects on the Company's future
operations are not predictable. The Company does not currently have a
hedging program to protect against foreign currency exposure and, in
certain of the countries in which the Company operates, no effective
hedging program is available.
RISK OF OPERATIONS IN YUGOSLAVIA
ICN Yugoslavia represents a material part of the Company's
business. Approximately 46% and 44% of the Company's net sales for
1995 and 1996, respectively, were from ICN Yugoslavia. In addition,
approximately 50% and 62% of the Company's operating income for 1995
and 1996, respectively, and approximately 45% and 32% of the Company's
net sales for the nine months ended September 30, 1996 and 1997,
respectively, were from ICN Yugoslavia. ICN Yugoslavia, a 75% owned
subsidiary, operates in a business environment that is subject to
significant economic volatility and political instability. The
economic conditions in Yugoslavia include continuing liquidity
problems, unemployment, a weakened banking system and a high trade
deficit. Between May 1992 and December 1995, ICN Yugoslavia operated
under United Nations' sanctions that severely limited the ability to
import raw materials and prohibited all exports. While the sanctions
have been suspended, certain risks, such as hyperinflation, currency
devaluations, wage and price controls and potential government action
could continue to have material adverse impact on the Company's
financial position and results of operations.
During 1992 and 1993, the rate of inflation in Yugoslavia was
over one billion percent per year. Inflation was dramatically reduced
in January 1994 when the government enacted a stabilization program
designed to strengthen its currency. This program reduced the
annualized inflation rate to five percent by the end of 1994,
increased the availability of hard currency, stabilized the exchange
rate of the dinar and improved the overall economy. In 1995, the
effectiveness of the stabilization program began to wane, resulting in
a decline in the availability of hard currency and an acceleration of
inflation to an annual rate of 90% by year end. In November 1995, the
dinar was devalued from a rate of 1.4 dinars per U.S.$1 to a rate of
4.7 dinars per U.S.$1.
During 1996, inflation increased further to an annual rate of 95%
and the availability of hard and local currency continued to decline.
The lifting of sanctions by the United Nations eventually provided
opportunities to export outside of Yugoslavia. A policy of strict
monetary control in Yugoslavia has kept inflation at a current annual
level of approximately 40%. However, Yugoslavia has not fully
recovered the international status it held before sanctions were
imposed and management believes that economic reform and privatization
is necessary before the economy will improve dramatically. The
Yugoslavian government is still negotiating to regain membership in
the International Monetary Fund and World Bank. Management believes
that the 1997 Presidential and parliamentary elections may result in
political change that would lead to economic reform, although such
elections also have the potential to create additional political
instability and currency devaluations.
In an effort by the National Bank of Yugoslavia to control
inflation through tight monetary controls, Yugoslavia is now
experiencing severe liquidity problems. This has resulted in longer
collection periods on ICN Yugoslavia's receivables. Most of ICN
Yugoslavia's customers are slow to pay due to delays of health care
payments by the government. This has also resulted in ICN Yugoslavia
being unable to make timely payments on its payables. ICN Yugoslavia
is attempting to reduce its receivables and improve its cash flow by
restricting future sales; however, these actions may result in sales
and earnings in 1997 that are lower than such amounts in 1996.
ICN Yugoslavia began the year with a net monetary asset exposure
of $134,000,000 which was subject to foreign exchange loss if a
devaluation of the dinar were to occur. During the first nine months
of 1997, the Company reduced its monetary exposure by converting
dinar-denominated accounts receivable into notes receivable payable in
dinars, but fixed in dollar amounts. The first conversion was made
early in the first quarter of 1997 with $50,000,000 of accounts
receivable converted into a one year note with interest at LIBOR plus
one percent. A second conversion was arranged at the end of the first
quarter of 1997 through an agreement with the Yugoslavian government
to purchase $50,000,000 of drugs. The sales under this agreement were
converted into a note receivable bearing interest at LIBOR plus one
percent on the outstanding balance and has special payment guarantees
with the payment fixed in dollar amounts. The second agreement also
allows the Company to offset payroll tax obligations against
outstanding accounts receivable balances. Subsequent to these two
agreements, the Company negotiated an arrangement with the government
of Yugoslavia under which ICN Yugoslavia would commit to continue to
provide products, in dollar denominated sales, in an amount up to
$50,000,000 per calendar quarter for one year, and the government
would pay a minimum of $9,500,000 per month towards outstanding
receivables. However, at no point in time can the amount due to ICN
Yugoslavia from the government exceed $200,000,000, including both
accounts and notes receivable. Receivables that arise from this
agreement are interest bearing with interest at the LIBOR rate plus
one percent. As of September 30, 1997, ICN Yugoslavia had a net
monetary asset position of $48,000,000 which would be subject to
foreign exchange loss if a devaluation of the dinar were to occur.
The Company was able to reduce its overall accounts receivable
balance from the beginning of the year through collections and the
conversion of $130,000,000 of accounts receivable into notes
receivable discussed above. As of September 30, 1997, the accounts
receivable balance was $74,471,000. The willingness of the Yugoslavian
government to provide the Company protection against devaluation on
its receivables in exchange for longer payment terms is a reflection
of the strict adherence to government policy on controlling inflation
by limiting the amount of hard currency in circulation. This policy
was initially established with the start of the stabilization program
in 1994.
With 80% of ICN Yugoslavia sales arising from government or
government-sponsored entities, ICN Yugoslavia is financially dependent
on the Yugoslavian government. Additionally, ICN Yugoslavia is also
subject to credit risk in that 60% of its December 31, 1996, domestic
accounts receivables and 31% of its year-to-date sales are with three
major customers.
ICN Yugoslavia is subject to price controls in Yugoslavia. The
size and frequency of government-approved price increases are
influenced by local inflation, devaluations, cost of imported raw
materials and demand for ICN Yugoslavia products. During 1995, 1996
and the first nine months of 1997, ICN Yugoslavia received fewer price
increases than in the past due to lower relative levels of inflation.
As inflation increases, the size and frequency of price increases are
expected to increase. Price increases obtained by ICN Yugoslavia are
based on economic events preceding such an increase and not on
expectations of ongoing inflation. A lag in approved price increases
could reduce the gross margins that ICN Yugoslavia receives on its
products. Although the Company expects that ICN Yugoslavia will limit
sales of products that have poor margins until an acceptable price
increase is received, the impact of an inability to obtain adequate
price increases in the future could have an adverse impact on the
Company as a result of declining gross profit margins or declining
sales in an effort to maintain existing gross margin levels.
RISK OF OPERATIONS IN RUSSIA, EASTERN EUROPE AND CHINA
The Company has invested a total of approximately $28,404,000 for
majority interests in five pharmaceutical companies located in Russia.
The Company also invested approximately $22,100,000 in its 60.0%
interest in ICN Hungary. In October 1997, the Company invested
approximately $33,700,000, and 31,700 shares of Common Stock valued at
$1,709,000 to be issued to certain employees (see "Selling
Stockholders"), in an 80% interest in Rzeszow, a pharmaceutical
company located in Poland, and has committed to invest an additional
$20,000,000 in 1998 and 1999, which will give the Company a 90%
interest in Rzeszow. In September 1996, the Company committed to
invest an aggregate of $24,000,000 in a joint venture with Jiangsu
Provincial Wuxi Pharmaceutical Corporation ("Wuxi"), a Chinese
state-owned pharmaceutical corporation. Although the Company believes
that investment in Russia, Eastern Europe, China and other emerging
markets offers access to growing world markets, the economic and
political conditions in such countries are uncertain. See "--
Dependence on Foreign Operations."
NO ASSURANCE OF SUCCESSFUL DEVELOPMENT AND COMMERCIALIZATION
OF FUTURE PRODUCTS
The Company's future growth will depend, in large part, upon its
ability to develop or obtain and commercialize new products and new
formulations of or indications for current products. The Company is
engaged in an active research and development program involving
compounds owned by the Company or licensed from others which the
Company may, in the future, desire to develop commercially. There can
be no assurance that the Company will be able to develop or acquire
new products, obtain regulatory approvals to use such products for
proposed or new clinical indications in a timely manner, manufacture
its potential products in commercial volumes or gain market acceptance
for such products. In addition, the Company may require financing over
the next several years to fund costs of development and acquisitions
of new products and, if Virazole(R) is approved for treatment of
chronic hepatitis C in Combination Therapy (for which there can be no
assurance), to expand the production and marketing of Virazole(R) in
the countries of the European Union, where the Company has retained
co-marketing rights under the License Agreement. It may be desirable
or necessary for the Company to enter into licensing arrangements with
other pharmaceutical companies in order to market effectively any new
products or new indications for existing products such as the License
Agreement with Schering for the marketing of Virazole(R) for
Combination Therapy (if approved). There can be no assurance that the
Company will be successful in raising such additional capital or
entering into such marketing arrangements, if required, or that such
capital will be raised, or such marketing arrangements will be, on
terms favorable to the Company.
LIMITED PATENT PROTECTION
The Company may be dependent on the protection afforded by its
patents relating to Virazole(R) and no assurance can be given as to
the breadth or degree of protection which these patents will afford
the Company. The Company has patent rights in the United States
expiring in 1999 relating to the use of Virazole(R) to treat specified
human viral diseases. If future development of Virazole(R) in
Combination Therapy is successful and approval is granted in the
United States, an additional award of exclusivity will be granted of
up to three years from date of approval (Waxman-Hatch Act); however,
there can be no assurance that such development will be successful or
that such approval will be obtained. While the Company has patents in
certain foreign countries covering the use of Virazole(R) in the
treatment of certain diseases, which coverage and expiration varies
and which patents expire at various times through 2006, the Company
has no, or limited, patent rights with respect to Virazole(R) and/or
its use in certain foreign countries where Virazole(R) is currently,
or in the future may be, approved for commercial sale, including
France, Germany and Great Britain. However, the Company and Schering
intend to file applications for approval of Combination Therapy
through a centralized procedure in the European Union (which includes
France, Germany and Great Britain). If such approval is granted, the
Company and Schering would be afforded either six or ten years
(depending upon the particular country) of protection for the
Combination Therapy against competition. There can be no assurance
that the loss of the Company's patent rights with respect to
Virazole(R) upon expiration of the Company's patent rights in the
United States, Europe and elsewhere will not result in competition
from other drug manufacturers or will not otherwise have a significant
adverse effect upon the business and operations of the Company.
As a general policy, the Company expects to seek patents, where
available, on inventions concerning novel drugs, techniques, processes
or other products which it may develop or acquire in the future.
However, there can be no assurance that any patents applied for will
be granted, or that, if granted, they will have commercial value or as
to the breadth or the degree of protection which these patents, if
issued, will afford the Company. The Company intends to rely
substantially on its unpatented proprietary know-how, but there can be
no assurance that others will not develop substantially equivalent
proprietary information or otherwise obtain access to the Company's
know-how. Patents for pharmaceutical compounds are not available in
certain countries in which the Company markets its products.
Marketing approvals in certain foreign countries provide an
additional level of protection for products approved for sale in such
countries.
UNCERTAIN IMPACT OF ACQUISITION PLANS
The Company intends aggressively to continue its strategy of
targeted expansion through the acquisition of compatible businesses
and product lines and the formation of strategic alliances, joint
ventures and other business combinations. Should the Company complete
any material acquisition, the Company's success or failure in
integrating the operations of the acquired company may have a material
impact on the future growth or success of the Company. Since some or
all of these potential acquisitions may be affected with the issuance
of Common Stock by the Company to the sellers of the businesses being
acquired or financed with the issuance of Common Stock or securities
convertible into Common Stock, the interest of existing stockholders
in the Company may be diluted (which dilution may be material
depending on the size and the number of acquisitions consummated).
Subject to sufficient authorized and unissued shares of Common Stock
being available, no stockholder approval of any acquisition
transaction would be required unless the number of shares of Common
Stock issued by the Company in connection with the transaction (or
series of related transactions) were to exceed 20% of the then
outstanding shares of Common Stock.
POTENTIAL LITIGATION EXPOSURE
ICN is a defendant in a consolidated class action lawsuit
alleging, among other things, violations of federal securities laws
(the "Class Action"). Plaintiffs alleged that ICN made
misrepresentations of material facts and omitted to state material
facts in 1994 and 1995 concerning the Company's NDA for the use of
Virazole(R) for monotherapy treatment of chronic hepatitis C (the
"Hepatitis C NDA"). In July 1997, the Company and the plaintiffs in
the Class Action agreed to settle the litigation for the sum of $15.0
million. The settlement is in the process of being documented and is
subject to the approval of the court. A settlement hearing is expected
to be held in January 1998. The Company intends to urge the district
court to approve the settlement of the Class Action. If the settlement
is not approved, and the Class Action proceeds to trial, the ultimate
outcome of any such trial cannot be predicted with certainty, and any
unfavorable outcome could have a material adverse effect on the
Company.
Pursuant to an Order Directing Private Investigation and
Designating Officers to Take Testimony, entitled In the Matter of ICN
Pharmaceuticals, Inc., (P-177) (the "Order"), a private investigation
is being conducted by the SEC with respect to certain matters
pertaining to the status and disposition of the Hepatitis C NDA. As
set forth in the Order, the investigation concerns whether, during the
period June 1994 through February 1995, the Company, persons or
entities associated with it and others, in the offer and sale or in
connection with the purchase and sale of ICN securities, engaged in
possible violations of Section 17(a) of the Securities Act and Section
10(b) of the Exchange Act and Rule 10b-5 thereunder, by having
possibly: (i) made false or misleading statements or omitted material
facts with respect to the status and disposition of the Hepatitis C
NDA; (ii) purchased or sold Common Stock while in possession of
material, non-public information concerning the status and disposition
of the Hepatitis C NDA; or (iii) conveyed material, non-public
information concerning the status and disposition of the Hepatitis C
NDA, to other persons who may have purchased or sold Common Stock. The
Company is cooperating with the Commission in its investigation. The
Company has and continues to produce documents to the SEC pursuant to
its request and the SEC has taken the depositions of certain current
and former officers, directors and employees of the Company.
The Company has received a Subpoena (the "Subpoena") from a Grand
Jury in the United States District Court, Central District of
California requesting the production of documents covering a broad
range of matters over various time periods. The Company and Milan
Panic, Chairman and Chief Executive Officer, are subjects of the
investigation. The Company has and continues to cooperate in the
production of documents pursuant to the Subpoenas. A number of current
and former employees of the Company have been interviewed by the
government in connection with the investigation.
The ultimate outcome of the SEC and Grand Jury investigations
cannot be predicted and any unfavorable outcome could have a material
adverse effect on the Company.
DEPENDENCE ON KEY PERSONNEL
The Company believes that its continued success will depend to a
significant extent upon the efforts and abilities of its management,
including Milan Panic, its Chairman, President and Chief Executive
Officer. The loss of their services could have a material adverse
effect on the Company. The Company cannot predict what effect, if any,
the Commission's investigation of the Company, as described under
"Potential Litigation Exposure," and the Subpoena may have on Mr.
Panic's ability to continue to devote services on a full time basis to
the Company. See " -- Potential Litigation Exposure," above. In
addition, Mr. Panic, who served as Prime Minister of Yugoslavia from
July 1992 to March 1993, remains active in Yugoslavian politics and
may again serve in a governmental office in the future.
POTENTIAL PRODUCT LIABILITY EXPOSURE AND LACK OF INSURANCE
The Company could be exposed to possible claims for personal
injury resulting from allegedly defective products. Even if a drug
were approved for commercial use by an appropriate governmental
agency, there can be no assurance that users will not claim that
effects other than those intended may result from the Company's
products. The Company generally self-insures against potential product
liability exposure with respect to its marketed products, including
Virazole(R). While to date no material adverse claim for personal
injury resulting from allegedly defective products, including
Virazole(R), has been successfully maintained against the Company or
any of its predecessors, a substantial claim, if successful, could
have a material adverse effect on the Company.
GOVERNMENT REGULATION
FDA approval must be obtained in the United States and approval
must be obtained from comparable agencies in other countries prior to
marketing or manufacturing new pharmaceutical products for use by
humans in such respective jurisdictions. Obtaining FDA approval for
new products and manufacturing processes can take a number of years
and involves the expenditure of substantial resources. Numerous
requirements must be satisfied, including preliminary testing programs
on animals and subsequent clinical testing programs on humans, to
establish product safety and efficacy. No assurance can be given that
authorization of the commercial sale of any new drugs or compounds by
the Company for any application or of existing drugs or compounds for
new applications will be secured in the United States or any other
country, or that, if such authorization is secured, those drugs or
compounds will be commercially successful.
The FDA in the United States and other regulatory agencies in
other countries also periodically inspect manufacturing facilities.
Failure to comply with applicable regulatory requirements can result
in, among other things, sanctions, fines, delays or suspensions of
approvals, seizures or recalls of products, operating restrictions and
criminal prosecutions. Furthermore, changes in existing regulations or
adoption of new regulations could prevent or delay the Company from
obtaining future regulatory approvals.
The Company is subject to price control restrictions on its
pharmaceutical products in the majority of countries in which it
operates. To date, the Company has been affected by pricing
adjustments in Spain and by the lag in allowed price increases in
Yugoslavia and Mexico, which have created lower sales in U.S. dollars
and reductions in gross profit. Future sales and gross profit could be
materially affected if the Company is unable to obtain price increases
commensurate with the levels of inflation.
COMPETITION
The Company operates in a highly competitive environment. The
Company's competitors, many of whom have substantially greater capital
resources and marketing capabilities and larger research and
development staffs and facilities than the Company, are actively
engaged in marketing products similar to those of the Company and in
developing new products similar to those proposed to be developed and
sold by the Company. Others may succeed in developing products that
are more effective than those marketed or proposed for development by
the Company. Progress by other researchers in areas similar to those
being explored by the Company may result in further competitive
challenges. In early 1996, MedImmune, Inc. began marketing in the
United States RespiGam(R), a prophylactic drug for the treatment of
RSV. The Company is aware of several other ongoing research and
development programs which are attempting to develop new prophylactic
and therapeutic products for treatment of RSV. Although the Company
will follow publicly disclosed developments in this field, on the
basis of currently available data, it is unable to evaluate whether
RespiGam(R) or the other technology being developed in these programs
poses a threat to the Company's current market position in the
treatment of RSV or its revenue streams. In addition, a number of
companies and researchers are engaged in developmental efforts for the
treatment of Hepatitis C, including through the use of protease
inhibitors. The Company may also face increased competition from
manufacturers of generic pharmaceutical products when certain of the
patents covering certain of its currently marketed products expire.
INDEBTEDNESS AND OTHER OBLIGATIONS OF THE COMPANY
As of September 30, 1997, after giving effect to the redemption
of certain indebtedness of the Company in November 1997 (see "Recent
Developments") and repayment of indebtedness related to the Company's
acquisition of a plant in Puerto Rico, the Company had outstanding
long-term debt of $342,000,000. The indenture for certain of the
Company's debt contains, and other debt instruments of the Company may
in the future contain, a number of significant covenants that, among
other things, restrict the ability of the Company to dispose of
assets, incur additional indebtedness, repay other indebtedness or
amend other debt instruments, pay dividends, create liens on assets,
enter into investments or acquisitions, engage in mergers or
consolidations, make capital expenditures or engage in certain
transactions with subsidiaries and affiliates, and otherwise restrict
certain corporate activities. The Company's strategy contemplates
continued strategic acquisitions, and a portion of the cost of such
acquisitions may be financed through additional indebtedness. There
can be no assurance that financing will continue to be available on
terms acceptable to the Company or at all. In the absence of such
financing, the Company's ability to respond to changing business and
economic conditions, to fund scheduled investments and capital
expenditures, to make future acquisitions or developments and to
absorb adverse operating results may be adversely affected.
RECENT DEVELOPMENTS
On November 16, 1997, the Company completed its redemption of its 8
1/2% Convertible Subordinated Notes due 1999 (the "8 1/2% Notes") at
102.125% of the principal amount plus accrued interest. In addition,
on November 7, 1997, the Company completed its redemption of the 5
5/8% Xr Capital Holding Exchangeable Certificates due 2001 (the "5
5/8% Certificates"), issued by a trust (the "Trust") established by
the Company in 1986, at 100% of the principal amount plus accrued
interest. In connection with the redemption of the 8 1/2% Notes,
$114,800,000 in principal amount were converted into 5,200,000 shares
of Common Stock, and the balance of $61,000 in principal amount was
redeemed for cash at 102.125% of the principal amount. In connection
with the redemption of the 5 5/8% Certificates, Swiss Francs
59,000,000 in principal amount were exchangeable into 1,300,000 shares
of Common Stock, and the balance of Swiss Francs 180,000 in principal
amount was redeemed for cash at 100% of the principal amount plus
accrued interest. As part of the redemption and the termination of the
Trust, Swiss Francs 36,000,000 of collateral was released and became
available to the Company for general corporate purposes.
On December 5, 1997, the Company acquired the U.S. rights to
Efudix and Librium from Roche and worldwide rights to Levo-Dromoran
and Tensilon from subsidiaries of Roche for a total aggregate purchase
price of approximately $89,000,000 (the purchase price for which was
paid utilizing the price appreciation in the Common Stock issued to
Roche in August 1997). In August 1997, the Company had acquired
worldwide rights to seven Roche products, rights outside of the United
States to Efudix and Librium and an option to obtain the U.S. rights
to these two products. See "The Company."
USE OF PROCEEDS
The Company will only receive proceeds from the exercise of the
Warrants and the issue of Common Stock upon the exercise of the
Warrants. If all of the 46,818 outstanding Warrants are exercised, the
Company will receive aggregate gross proceeds of approximately
$870,000.
No assurance can be given, however, that all or any portion of
the Warrants will be exercised. If any of the Warrants are exercised,
the Company intends to use the proceeds for general corporate
purposes.
The Company will not receive any of the proceeds from the sale of
the 551,595 shares of Common Stock that may be issued to the
Certificate holders, upon the exchange of the Certificates from and
after the Merger described above, or from any sales of the 31,700
shares of Common Stock by the Rzeszow Employees.
Warrant holders are referred to the terms of the Warrants and the
related agreements relating to the Warrants for information regarding
their exchange rights. A copy of the Warrant Agreement is attached as
an exhibit to the Registration Statement of which this Prospectus is a
part.
Certificate holders are referred to the terms of the Certificates
and the related agreements pertaining to such rights for information
regarding their exchange rights. Copies of the indenture and related
documents are attached as an exhibit to the Registration Statement of
which this Prospectus is a part.
The transfer agent for the Common Stock is the American Stock
Transfer & Trust Company unless and until a successor is selected by
the Company.
SELLING STOCKHOLDERS
The Company agreed to issue 50 Shares to each of the Rzeszow
Employees in an offering made outside of the United States under
Regulation S of the Securities Act. The total number of Shares to be
offered to the Rzeszow Employees is 31,700 Shares. This Prospectus
covers the resale from time to time of the Rzeszow Shares. Because the
Rzeszow Employees may sell all or part of the Rzeszow Shares that they
hold pursuant to this Prospectus and because this Offering is not
being underwritten on a firm commitment basis, no estimate can be
given as to the amount of the Company's Shares that will be held by
the Rzeszow Employees upon termination of this Offering.
As of December 16, 1997, the Company had outstanding
approximately 47,514,194 shares of Common Stock. The Shares to be sold
by the Rzeszow Employees represent in the aggregate less than 1% of
the outstanding shares of Common Stock.
PLAN OF DISTRIBUTION
If all of the Warrants outstanding as of December 4, 1997, were
exercised, 46,818 shares of Common Stock would be issued. The Warrants
were issued pursuant to a Warrant Agreement between the Company and
Meyers, and have usual and customary antidilution provisions as more
fully described in the Warrant Agreement. The Warrants are exercisable
until 5:00 p.m., Pacific Time, on January 27, 1998 at an exercise
price of $18.7151 per share. This Prospectus also has been prepared
for the benefit of the Certificate holders who exchange Certificates
for the Common Stock. There can be no assurance that any of the
Warrant holders or Certificate holders will exchange any of the
Warrants or Certificates into Common Stock.
The Rzeszow Shares may be sold from time to time by the Rzeszow
Employees or by their transferees and assigns. Such sales may be made
in the over-the-counter market, on the NYSE or other exchanges (if the
Common Stock is listed for trading thereon), or otherwise at prices
and at terms then prevailing, at prices related to the then current
market price or at negotiated prices. The Rzeszow Shares may be sold
by any one or more of the following methods: (a) a block trade in
which the broker or dealer so engaged will attempt to sell the
securities as agent but may position and resell a portion of the block
as principal to facilitate the transaction; (b) purchases by a broker
as principal and resale by such broker or dealer for its account; (c)
ordinary brokerage transactions and transactions in which the broker
solicits purchasers; and (d) privately negotiated transactions. In
addition, any Rzeszow Shares that qualify for sale pursuant to Rule
144 may be sold under Rule 144 rather than pursuant to this
Prospectus.
The Rzeszow Employees and any broker-dealers, agents or
underwriters that participate with the Rzeszow Employees in the
distribution of the Rzeszow Shares may be deemed to be "underwriters"
within the meaning of the Securities Act and any commissions received
by such broker-dealer, agent or underwriter and any profit on the
resale of the Rzeszow Shares purchased by them may be deemed to be
underwriting commissions or discounts under the Securities Act.
Under the Exchange Act and the regulations thereunder, any person
engaged in a distribution of the Rzeszow Shares offered by this
Prospectus may not simultaneously engage in market making activities
with respect to the Common Stock, during any applicable "restricted
period" prior to the commencement of such distribution. In addition,
and without limiting the foregoing, the Rzeszow Employees will be
subject to applicable provisions of the Exchange Act and the rules and
regulations thereunder including, without limitation, Regulation M,
the provisions of which may limit the timing of purchases and sales of
Common Stock by the Rzeszow Employees.
To the extent required, the Company will use its best efforts to
file, during any period in which exchanges are being made, one or more
supplements to this Prospectus to describe any material information
with respect to the plan of distribution not previously disclosed in
this Prospectus or any material change to such information in this
Prospectus.
LEGAL MATTERS
The legality of the Common Stock offered hereby will be passed
upon for the Company by David C. Watt, Executive Vice President,
General Counsel and Corporate Secretary of the Company. As of December
16, 1997, Mr. Watt beneficially owned 99,673 shares of Common Stock,
including 97,678 shares which he has the right to acquire upon the
exercise of currently exercisable stock options.
INDEPENDENT PUBLIC ACCOUNTANTS
The consolidated balance sheets as of December 31, 1996 and 1995,
and the consolidated statements of income, stockholders' equity and
cash flows for each of the three years in the period ended December
31, 1996, incorporated by reference in this Prospectus, have been
included herein in reliance on the report, which includes an emphasis
of matter paragraph related to the Company's net monetary assets at
ICN Yugoslavia which would be subject to foreign exchange loss if a
devaluation of the dinar were to occur, of Coopers & Lybrand L.L.P.,
independent public accountants, given on the authority of that firm as
experts in auditing and accounting. With respect to the unaudited
interim financial information for the periods ended September 30, 1997
and 1996, incorporated by reference in this Prospectus, the
independent accountants have reported that they have applied limited
procedures in accordance with professional standards for a review of
such information. However, their separate report included in the
Company's quarterly report on Form 10-Q for the quarters ended March
31, June 30 and September 30, 1997, and incorporated by reference
herein, states that they did not audit and they do not express an
opinion on that interim financial information. Accordingly, the degree
of reliance on their reports on such information should be restricted
in light of the limited nature of the review procedures applied. The
accountants are not subject to the liability provisions of Section 11
of the Securities Act for their report on the unaudited interim
financial information because that report is not a "report" or a
"part" of the Registration Statement prepared or certified by the
accountants within the meaning of Sections 7 and 11 of the Securities
Act.
Any financial statements and schedules hereafter incorporated by
reference in the Registration Statement of which this Prospectus is a
part, that have been audited and are the subject of a report by
independent accountants will be so incorporated by reference in
reliance upon such reports and upon the authority of such firms as
experts in accounting and auditing to the extent covered by consents
filed with the Commission.
NO DEALER, SALESPERSON OR ANY OTHER PERSON HAS BEEN AUTHORIZED TO
GIVE ANY INFORMATION OR TO MAKE ANY REPRESENTATIONS, OTHER THAN THOSE
CONTAINED IN THIS PROSPECTUS, IN CONNECTION WITH THIS OFFERING, AND,
IF GIVEN OR MADE, SUCH OTHER INFORMATION OR REPRESENTATION MUST NOT BE
RELIED UPON AS HAVING BEEN AUTHORIZED BY THE COMPANY. NEITHER THE
DELIVERY OF THIS PROSPECTUS NOR ANY SALE MADE HEREUNDER SHALL, UNDER
ANY CIRCUMSTANCES, CREATE ANY IMPLICATION THAT THERE HAS BEEN NO
CHANGE IN THE AFFAIRS OF THE COMPANY SINCE THE DATE OF THIS
PROSPECTUS. THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER OR
SOLICITATION BY ANYONE IN ANY STATE IN WHICH SUCH OFFER OR
SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON MAKING SUCH
OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO OR TO ANYONE TO WHOM
IT IS UNLAWFUL TO MAKE SUCH OFFER OR SOLICITATION.
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TABLE OF CONTENTS
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Page
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Prosectus Summary........................................ 1
The Company.............................................. 2
Available Information.................................... 2
Incorporation of Certain Documents by
Reference............................................. 3
Risk Factors............................................. 6
Recent Developments...................................... 12
Use of Proceeds.......................................... 12
Selling Stockholders..................................... 13
Plan of Distribution..................................... 13
Legal Matters............................................ 14
Independent Public Accounts.............................. 14
630,113 Shares
ICN Pharmaceuticals, Inc.
Common Stock
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Prospectus
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December 19, 1997
